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RECRUITING
NCT05444127

Oral Health and Wilson's Disease: SOMAWI

Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

View on ClinicalTrials.gov

Summary

Patients with Wilson disease have poorer dental and periodontal health and a have lower oral quality of life than control patients. Patients with a neurological form would also more frequently present limitations in the function of the masticatory apparatus. Systemic treatments for Wilson disease are associated with lesions of the oral mucosa. Analysis of copper level in saliva could testify to the effectiveness of copper depletion in treated patients The main objective is to compare the state of dental health between: patients with Wilson disease in the hepatic form and patients with the neurological form, and a population of controls.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2023-05-17

Completion Date

2026-10

Last Updated

2025-12-17

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Saliva samples

A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire.

OTHER

Questionnaire OHIP-14

A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire.

OTHER

Thorough dental examination

A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire.

Locations (3)

Hopital Charles Foix

Ivry-sur-Seine, France

Hôpital Charles Foix

Ivry-sur-Seine, France

Fondation Adolphe de Rothschild

Paris, France